The Link Between Drug Importation and Counterfeit Drugs

Last week, BBC File On 4 published a story detailing how counterfeit drugs infiltrated the United Kingdom’s national drug supply in 2007. The Medicines Health products Regulatory Agency (MHRA)—the British equivalent of the U.S. Food and Drug Administration—issued four emergency recalls notices after a wholesaler spotted packaging discrepancies in several drugs imported from other European countries.

But it was too late. The counterfeit drugs were in the supply chain. Thousands of fake stroke, prostate cancer and schizophrenia medications had been distributed to pharmacists, doctors, hospitals and patients by the time the recalls were issued. These counterfeit drugs—imported using parallel trade agreements—contained only 50-80 percent of the correct active pharmaceutical ingredients. This created a serious health risk since even a small discrepancy denies patients the therapies needed to alleviate suffering and save lives.

Today, the MHRA estimates that there are still 30,000 packs of the counterfeit drugs unaccounted for (out of the estimated 70,000 packs in the supply chain). This is because in the U.K. pharmacists are not obligated to keep a record of drug batch numbers, nor to maintain dispensation records.

How do events in the UK and European countries impact on U.S. patients? The ringleader of this group, having successfully penetrated the European markets had bigger plans. He was arrested by U.S. ICE agents as he conspired to expand his operations by shipping counterfeit medicines into the U.S.

As Congress considers the FDA Globalization Act of 2009, it’s important that our policymakers don’t undermine our existing and proposed drug safety protocols by allowing drug importation. To learn more about the issues threatening the safety of our prescription drugs, visit www.safemedicines.org.